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Investigating the effect of hydroalcoholic extract of Teucrium polium ointment on the healing process of second degree burn wounds

Protocol summary

Study aim
Investigating the effect of hydroalcoholic extract ointment of Teucrium polium on the healing process of burn wounds
Design
During days 1, 3, 6, 9, and 14, the wound surface will be photographed by a 12 MP, f/1.7, 26mm (wide), 1/2.55", 1.4µm camera from similar distance and area. The wound area will be calculated using Digimizer software. On the mentioned days, the wound is also evaluated and scored by the Betts Jensen's wound evaluation tool. On the sixth day of the study, a culture of Staphylococcus aureus and Pseudomonas is prepared from the wound.
Settings and conduct
Patients with second degree burns who refer to our hospital will be selected; the study is in the form of a clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: -Second degree burns injury -Absence of underlying disease Exclusion criteria: -Electrical or chemical burns -Burn wounds that require debridement -Transfer from another treatment center -Burn area more than 40% (according to Lund and Browder chart) -The burn wound is stained with substances -Allergy to the prepared ointment -Reluctance to participate in the study -Wound infection
Intervention groups
In this experimental study, 76 patients who suffered from second-degree thermal burns injury will be examined in two similar areas of their body. One area as the experimental group is the place where the extract is used as an ointment for ten days and the opposite area is the control group. Silver sulfadiazine ointment is applied for the control group.
Main outcome variables
Investigating and comparing the rate of wound healing and its area using the Betts-Johnson criterion and photographing the wound on the first, third, sixth, ninth, and the fifteenth days, and examining the wound culture for Staphylococcus aureus and Pseudomonas on the sixth day between the control and intervention groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230429058024N1
Registration date: 2024-07-15, 1403/04/25
Registration timing: registered_while_recruiting

Last update: 2024-07-15, 1403/04/25
Update count: 0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Babak Rastegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 0853
Email address
babak.rst@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of hydroalcoholic extract of Teucrium polium ointment on the healing process of second degree burn wounds
Public title
Investigating the effect of hydroalcoholic extract of Teucrium polium ointment on the healing process of second degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Second degree burns wound Thermal injury
Exclusion criteria:
No underlying disease Electrical or thermal burn
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used. For this purpose, the names of different groups are written in the envelopes, and one is chosen for each patient.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
9417694780
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
4010036

Health conditions studied

1

Description of health condition studied
Second-degree Burns injury
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned

Primary outcomes

1

Description
Wound area
Timepoint
On days 1, 3, 6, 9, and 14
Method of measurement
Ruler and photography

Secondary outcomes

1

Description
Wound healing rate
Timepoint
On the 1st, 6th, 9th and 14th days
Method of measurement
Bates-Johnson criterion and imaging

2

Description
Wound infection in terms of Staphylococcus aureus and Pseudomonas
Timepoint
The sixth day
Method of measurement
Wound culture

Intervention groups

1

Description
Intervention group: Patient with second degree burns injury who used extract ointment on a part of wound for 14 days.
Category
Treatment - Drugs

2

Description
Control group: Patient with second degree burns injury who used silver sulfadiazine ointment on a part of the wound for 14 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Babak Rastegar
Street address
Montazeri St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
beheshtihospital@yasooj.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini Motlagh
Street address
Shahid Motahari Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
research@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Babak Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No.135, 9 Alley, West Golchin St. Shiraz, Fars
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7185896193
Phone
+98 913 832 5429
Email
babak.rst@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Babak Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Jalil hospital, Gharani Blvd, Yasuj, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7185896193
Phone
+98 71 3233 0853
Fax
Email
babak.rst@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Babak Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 135, 9 Alley, West Golchin St., Shiraz, Fars, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7185896193
Phone
+98 913 832 5429
Email
babak.rst@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
A decision will be made with the collective opinion of all project managers.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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